Bioepis' Remicade biosimilar Flixabi approved in EU

31 May 2016

The European Commission has granted marketing authorization in the European Union for Flixabi, an infliximab biosimilar referencing Remicade,Johnson & Johnson and Merck & Co's Remicade (infliximab), for the treatment of rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Flixabi was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and US biotech major Biogen (Nasdaq: BIIB). Flixabi is indicated for the treatment of adults with RA, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Additionally, it can be used in patients six to 17 years old with severe, active Crohn’s disease or severely active ulcerative colitis.

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